This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
OMESAR® 10 mg, 20 mg, 40 mg Film-Coated Tablets
olmesartan medoxomil
1. What is Omesar and what it is used for 2. Before you take Omesar 3. How to take Omesar 4. Possible side effects 5. How to store Omesar 6. Further information
Omesar belongs to a group of medicines called angiotensin-II receptor antagonists. They lower blood pressure by relaxing the blood vessels.
Omesar is used for the treatment of high blood pressure (also known as ‘hypertension’). High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain and eyes. In some cases this may lead to a heart attack, heart or kidney failure, stroke or blindness. Usually high blood pressure has no symptoms. It is important to have your blood pressure checked to prevent damage occurring.
High blood pressure can be controlled with medicines such as Omesar tablets. Your doctor has probably also recommended that you make some changes in your lifestyle to help lower your blood pressure (for example losing weight, giving up smoking, reducing the amount of alcohol you drink and reducing the amount of salt in your diet). Your doctor may also have urged you to take regular exercise, such as walking or swimming. It is important to follow this advice from your doctor.
Before you take the tablets, tell your doctor if you have any of the following health problems:
As with any medicine which reduces blood pressure, an excessive drop in blood pressure in patients with blood flow disturbances of the heart or brain could lead to a heart attack or stroke. Your doctor will therefore check your blood pressure carefully.
You must tell your doctor if you think you are (or might become) pregnant. Omesar is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Please tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Omesar can be taken with or without food. Swallow the tablets with a little water. If possible, take your daily dose at the same time each day, for example at breakfast time.
Omesar is not recommended for children and adolescents under the age of 18.
If you are over 65 years of age and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, then you need to have your blood pressure regularly checked by your doctor to make sure that your blood pressure does not become too low.
As with other similar drugs the blood pressure lowering effect of Omesar is somewhat less in black patients.
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Omesar before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Omesar. Omesar is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Omesar is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
It is unlikely that Omesar will affect your ability to drive or operate machinery. However, dizziness or fatigue can occasionally occur during the treatment of high blood pressure. If you notice such effects, do not drive or use machines until the symptoms wear off. Ask your doctor for advice.
This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take Omesar exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The tablets can be taken with or without food. Swallow the tablets with a little water. If possible, take your daily dose at the same time each day, for example at breakfast time.
The usual starting dose is one 10 mg tablet once a day. However, if your blood pressure is not controlled, your doctor may decide to change your dose up to 20 or 40 mg once a day, or prescribe additional medicines.
In patients with mild to moderate kidney disease, your dose will not be higher than 20 mg once a day.
If you take more tablets than you should or if a child accidentally swallows some, go to your doctor or nearest emergency department immediately and take your medicine pack with you.
If you forget a dose, take your normal dose on the following day as usual. Do not take any extra tablets to make up for the missed dose.
It is important to continue to take Omesar unless your doctor tells you to stop.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Omesar can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped.
Although not many people may get them, the following two side effects can be serious:
On very rare occasions the following allergic reactions have been reported:
Swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur during treatment with Omesar. If this happens stop taking Omesar and contact your doctor immediately.
Rarely (but slightly more often in elderly patients) Omesar can cause the blood pressure to fall too low in susceptible individuals. This could cause severe light-headedness or fainting. If this occurs stop taking Omesar, contact your doctor immediately and lie down flat.
To give you an idea of how many patients might get side effects, they have been listed as common, uncommon, rare and very rare. These mean the following:
Common less than 1 in 10 people.
Uncommon less than 1 in 100 people.
Rare less than 1 in 1,000 people.
Very rare less than 1 in 10,000 people.
Common side effects:
Dizziness, nausea, indigestion, diarrhoea, stomach ache, gastroenteritis, tiredness, sore throat, runny or stuffy nose, bronchitis, flu-like symptoms, cough, pain in the chest, back, bones or joints, infection of the urinary tract, swelling of ankles, feet, legs, hands, or arms, blood in the urine.
Some changes in blood test results have also been seen and include the following:
increased fat levels (hypertriglyceridaemia), increased uric acid levels (hyperuricaemia), increases in tests of liver and muscle function.
Uncommon side effects:
Vertigo, skin rash, angina (pain or uncomfortable feeling in the chest).
Rare side effects:
Rarely, blood test results have shown increased potassium levels (hyperkalaemia).
Very rare side effects:
Headache, muscle cramps and muscular pain, impaired kidney function, kidney failure, weakness, lack of energy, feeling unwell, vomiting, itching, exanthema (skin eruption).
Some changes in blood test results have also been seen. These include increased levels of compounds related to kidney function and reduced numbers of a type of blood cell, known as platelets (thrombocytopenia).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Omesar after the expiry date (“EXP”) which is stated on the box and on the blister strip. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Omesar contains
The active substance is olmesartan medoxomil
Each film-coated tablet contains 10 mg, 20 mg or 40 mg olmesartan medoxomil.
Other ingredients are
microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low substituted hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171), talc and hypromellose.
What Omesar looks like and contents of the pack
Omesar 10 mg film-coated tablets are white, circular with C 13 on one side.
Omesar 20 mg film-coated tablets are white, circular with C 14 on one side.
Omesar 40 mg film-coated tablets are white, oval with C 15 on one side.
Omesar film-coated tablets are available in packs of 14, 28, 30, 56, 84, 90, 98 and 10 x 28 film-coated tablets and in packs with perforated unit dose blisters of 10, 50 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
or alternatively
This medicinal product is authorized in the Member States of the EEA under the following names:
Austria: Olmetec, Mencord
Belgium: Olmetec, Belsar
Cyprus: Olartan
Czech Republic: Olmetec, Sarten
Denmark: Olmetec, Benetor
Germany: Olmetec, Olmes, Votum
Greece: Olmetec, Olartan
Finland: Olmetec, Benetor
France: Olmetec, Olmes, Alteis
Iceland: Olmetec, Benetor
Ireland: Benetor, Omesar
Italy: Olmetec, Plaunac, Olpress
Luxembourg: Olmetec, Belsar
Malta: Omesar
The Netherlands: Olmetec
Norway: Olmetec, Benetor
Poland: Olmetec, Revival
Portugal: Olmetec, Olsar
Slovenia: Tensiol
Spain: Olmetec, Openvas, Ixia
UK: Olmetec
This leaflet was last revised in 02/2011.
Marketing Authorisation Holder:
Marketed by:
under licence of DAIICHI SANKYO EUROPE GmbH
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